FDA to review personal gene-testing kits

CONSUMERS

Catherine Larkin, Bloomberg News

Published 4:00 am, Saturday, June 12, 2010

Photo: Sandy Huffaker, Bloomberg News

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EDITOR'S NOTE: PHOTOS EMBARGOED UNTIL 00:01 MAY 11, 2010. A gene-testing kit sits on a table at Pathway Genomics Corp. in San Diego, California, U.S., on Monday, May 10, 2010. Pathway Genomics is preparing to sell gene-testing kits in Walgreens stores next week, a step likely to generate questions about how consumers may use and understand test results that many doctors have trouble interpreting. Photographer: Sandy Huffaker/Bloomberg less

EDITOR'S NOTE: PHOTOS EMBARGOED UNTIL 00:01 MAY 11, 2010. A gene-testing kit sits on a table at Pathway Genomics Corp. in San Diego, California, U.S., on Monday, May 10, 2010. Pathway Genomics is preparing to ... more

Photo: Sandy Huffaker, Bloomberg News

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EDITOR'S NOTE: PHOTOS EMBARGOED UNTIL 00:01 MAY 11, 2010. Lab technician Jarrod Morgan tests DNA samples at Pathway Genomics Corp. in San Diego, California, U.S., on Monday, May 10, 2010. Pathway Genomics is preparing to sell gene-testing kits in Walgreens stores next week, a step likely to generate questions about how consumers may use and understand test results that many doctors have trouble interpreting. Photographer: Sandy Huffaker/Bloomberg *** Local Caption *** Jarrod Morgan less

Personal genetic tests sold by five companies require regulatory review before sale, U.S. regulators said, one month after Walgreens scrapped plans to sell a similar product in its stores.

Consumers may make decisions based on the outcome of these tests, which should be reviewed under the same process used for medical devices, the Food and Drug Administration said in letters released Friday to 23andMe of Mountain View, Navigenics of Foster City, deCODE Genetics, Illumina Inc. and Knome Inc. The agency will decide whether the products can remain on the market after hearing what claims the companies want to make about their benefits.

The regulatory letters posted are the first sign that the government agency plans to crack down on companies marketing products that claim to predict inheritable diseases using DNA samples.

23andMe, deCODE Genetics and Illumina market tests that screen patients for their likelihood of developing health conditions or their response to various drugs. None of the companies have submitted their tests for approval, according to the FDA.

Navigenics and Knome make high-grade testing and software equipment that genetic companies use to analyze DNA samples. Under FDA regulations, those technologies must also undergo review as medical devices.

FDA asks each of the companies to contact the agency to make arrangements for submitting their products for review.

The FDA began taking a closer look at DNA tests last month when Pathway Genomics in San Diego announced it would begin selling its products through Walgreens, the largest drugstore chain in the country. Lawmakers led by Rep. Henry Waxman, D-Los Angeles, have urged companies to supply evidence that their tests are reliable.

"Premarket review of medical devices enables FDA to protect the public from medical products that may pose an unreasonable risk of harm," the FDA said in its letters. "It is important that they be analytically and clinically accurate so that individuals are not misled by incorrect test results or unsupported clinical interpretations."

Illumina, DeCode and Navigenics didn't return calls seeking comment. Spokesmen at Knome, which is in Cambridge, Mass., and 23andMe said they couldn't comment yet because they had not seen the letters.

The proliferation of consumer-marketed genetic tests has troubled many public health officials and doctors who worry that the products are built on flimsy data.

The biology of how DNA variations actually lead to certain diseases is still poorly understood, although a number of public and private institutions have been racing to find answers.

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